Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound

University of Miami

Status and phase: Completed; Phase 3

Conditions: ACL Injury

Treatments: Drug: OOC

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04993339

20150981

Details and patient eligibility

About

The goal of this study is to determine whether the use of injectable osteoinductive/osteoconductive compounds (OOC) during Anterior Cruciate Ligament (ACL) reconstructive surgery, combined with an accelerated rehabilitation protocol (ARP) provides clinical outcomes superior to those attained via traditional ACL reconstruction and delayed rehabilitation protocols.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• any adult undergoing a surgical procedure for hamstring ACL reconstruction

Exclusion criteria

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Standard Surgery

No Intervention group

Description:

Participants in this group undergoing standard of care reparative surgery will not receive additional intervention

Standard Surgery with OOC

Experimental group

Description:

Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention

Treatment:

Drug: OOC